Balloon dilation of the Eustachian tube with a seeker‐based device: A registry of 169 patients

Abstract

Objective: To collect real-world data on the safety and effectiveness of balloon dilation of the Eustachian tube using a seeker-based device in patients with persistent/chronic symptoms of Eustachian tube dysfunction. Methods: A multicenter, prospective, single-arm registry was conducted from June 2018 through August 2020 at 10 US centers, including tertiary care and private practices. Primary endpoints included mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) and the serious related adverse event rate. Secondary endpoints include changes in middle ear assessments, surgical intervention rate, and changes in Sino-Nasal Outcome Test and Work and Activity Impairment (WPAI) questionnaires.Results: A total of 169 participants were treated with balloon dilation of the Eustachian tube, with 166 and 154 participants completing the 6-week and 6-month follow-ups, respectively. Repeated measures analysis of the change in ETDQ-7 scores indicated statistically significant improvement (À2.1; 95% CI À2.40, À1.84; P < .0001) at 6-month follow-up. The minimum clinically important difference of improvement was achieved by 85% of participants at 6 months. Four nonserious adverse events were reported. Middle ear functional assessments were improved in the majority of participants with abnormal baseline findings. There were no statistically significant differences in the change from baseline ETDQ-7 scores between participants who had concurrent procedures and those who did not. WPAI scores demonstrated significant improvement. Conclusion:Real-world evidence supports the clinical studies demonstrating that balloon dilation of the Eustachian tube with a seeker-based device is a safe and effective procedure to treat ETD symptoms.

Application of B-ultrasound for localization and its impact on first-attempt success rates of nasogastric tube insertion in critically ill patients

“…Other methods often lack sensitivity and accuracy due to various influencing factors. [22][23][24] Although innovations and improvements have been made in positioning methodology, such as the injection of methylene blue, gastric electrode monitoring, and magnetic navigation, these methods are subject to strong subjectivity and can be affected by gastrointestinal function. [25][26][27] While the blind insertion method does not require specialized instruments, the human body's complex anatomical structure lowers the success rate of catheterization, lengthens the time required for the tube to pass through the pylorus, and necessitates multiple X-ray exams to determine the catheter tip's position.…”

Balloon dilation improves both the hearing level and the quality of life in patients suffering from obstructive Eustachian tube dysfunction

“…Adjunctive procedures were not used in this study and it is possible that appropriate other interventions may have improved clinical results. In a recent multicenter real-world study of 154 patients by Standring et al [ 21 ] in which adjunctive procedures were employed in several cases, minimum clinically important improvement was reported in 85%. The present study was done in the absence of adjunctive procedures to isolate the benefit of BET alone.…”

Balloon Eustachian tuboplasty for obstructive Eustachian tube dysfunction: retrospective multicentre cohort study of 248 patients

“…When there is no explanation for a dynamic or anatomical cause, the condition is classified as functional, usually related to mucosa thickening due to upper airway inflammation [ 1 , 2 ]. Baro-challenge is a subclinical variant of OETD in which the symptoms present only under conditions of atmospheric pressure changes (for example scuba diving or flying) [ 3 ].…”